title: Palonosetron plus dexamethasone in highly emetogenic chemotherapy: pooled data from two Phase III trials.
abstract: OBJECTIVE
  Data from two randomized trials were pooled to further characterize the effectiveness of palonosetron combined with dexamethasone in the setting of highly emetogenic chemotherapy.
  
  
  METHODS
  The analysis included 1411 patients who were randomized to receive palonosetron or ondansetron/granisetron intravenously on day 1 plus either 1-day or 3-day dexamethasone dosing. The primary end point was complete response (no vomiting and no rescue antiemetics over days 1-5) in cycle one. Data across the studies were analyzed by the Mantel-Haenszel method.
  
  
  RESULTS
  The vast majority of patients received either cisplatin (62%) or anthracycline plus cyclophosphamide (34%). The palonosetron regimen provided a 12 percentage-point improvement in the rate of overall complete response compared with the control regimen (49.2 vs 37.3%; odds ratio: 1.65; 95% CI: 1.33-2.04; p < 0.0001). The frequency of no delayed nausea at all daily periods was consistently higher in the palonosetron group.
  
  
  CONCLUSIONS
  The current analysis confirmed that palonosetron plus dexamethasone improved control of highly emetogenic chemotherapy-induced nausea and vomiting throughout 5 days postchemotherapy to a significantly greater extent than the combination including older 5-HT3 antagonists.
authors.affiliation: Medical Oncology Unit 1, Fondazione IRCCS 'Istituto Nazionale Tumori', Milan, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Celio
authors.forename: Francesco
authors.initials: F
authors.lastname: Agustoni
authors.forename: Francesca
authors.initials: F
authors.lastname: Ricchini
authors.forename: Katia
authors.initials: K
authors.lastname: Dotti
authors.forename: Monica
authors.initials: M
authors.lastname: Niger
authors.forename: Filippo De
authors.initials: FD
authors.lastname: Braud
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000188:drug therapy*; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D000077924:Palonosetron; D011812:Quinuclidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000188:drug therapy*
chemical_list: D007546:Isoquinolines; D011812:Quinuclidines; D000077924:Palonosetron; D003907:Dexamethasone